FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LEAD STYLET,MODELS 6505,6506,6507,6508
K Number: K992863
·
Decision Nov 12, 1999
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
27
Applicant Total
71
Review Days
79
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- LEAD STYLET,MODELS 6505,6506,6507,6508
- K Number
- K992863
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1380
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Guidant Corp.
- Date Received
- August 25, 1999
- Decision Date
- November 12, 1999
- Product Code
- DRB
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DRB | Stylet, Catheter | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DRB), ordered by most recent decision date.
Arrow Stiffening Stylet
FDA 510(k)
FDA Class 2
·Cardiovascular
Biotronik Stylets
FDA 510(k)
FDA Class 2
·Cardiovascular
GaltTWS
FDA 510(k)
FDA Class 2
·Cardiovascular
Liberator Beacon Tip Locking Stylet
FDA 510(k)
FDA Class 2
·Cardiovascular
LLD EZ
FDA 510(k)
FDA Class 2
·Cardiovascular
STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Guidant Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K061865 | FLEX 10 MIS ABLATION PROBE, MODEL FLX10MI-05 | Jul 27, 2006 | Substantially Equivalent |
| K061453 | HI-TORQUE WHISPER VIEW GUIDE WIRE | Jun 22, 2006 | Substantially Equivalent |
| K042908 | RX ACCUNET 2 EMBOLIC PROTECTION SYSTEM | Nov 12, 2004 | Substantially Equivalent |
| K042218 | ACCUNET EMBOLIC PROTECTION SYSTEM, RX ACCUNET EMBOLIC PROTECTION SYSTEM | Aug 31, 2004 | Substantially Equivalent |
| K033834 | OMNILINK .018 BILIARY STENT SYSTEM | Jan 2, 2004 | Unknown |
| K033393 | ABSOLUTE .035 SELF-EXPANDING BILIARY STENT SYSTEM | Nov 10, 2003 | Unknown |
| K031678 | HI-TORQUE BALANCE INIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING | Aug 26, 2003 | Substantially Equivalent |
| K031459 | RAPIDO CUT-AWAY CUTTER | Jul 23, 2003 | Substantially Equivalent |
| K031398 | IS-1 HEMOSTASIS VALVE, MODEL 6799 | May 20, 2003 | Substantially Equivalent |
| K030512 | GUIDANT VASOVIEW ENDOSCOPIC VESSEL HARVESTING SYSTEM | May 14, 2003 | Substantially Equivalent |